BARD-PARKER® SAFESWITCH¿ REUSABLE SCALPEL HANDLE, SIZE 7, NON-STERILE

Additional Manufacturer Narrative

ASPEN SURGICAL RECEIVED A REPORT FROM THE END USER INDICATING THAT DURING A PROCEDURE, THE SCALPEL CAME OFF OF THE SCALPEL HANDLE WHICH REQUIRED RETRIEVAL. NO SAMPLE OR PHOTOGRAPHIC WAS PROVIDED. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. A MANUFACTURING LOT NUMBER WAS PROVIDED FOR REVIEW. AS REPORTED BY THE END USER, DURING A SHOULDER PROCEDURE THE BLADE CAME OFF THE HANDLE INSIDE THE PATIENT. THE BLADE REQUIRED RETRIEVAL. THE DOCTOR HAD INSERTED THE BLADE/HANDLE INTO THE SHOULDER TO MAKE AN INCISION AND WHEN PULLING THE HANDLE OUT OF THE BODY, THE BLADE CAME OFF THE HANDLE INSIDE THE PATIENT. PATIENT WAS NOT HARMED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NON-CONFORMANCE'S RELATED TO THE REPORTED ISSUE. ACTUAL DEVICE IN USE WAS NOT RETURNED, HOWEVER REMAINING UNITS FROM PACKAGE WERE TESTED WITH NO BLADE RETENTION ISSUES. BASED ON REMAINING UNITS AND LOT NUMBER REVIEW, CAUSE IS NOT ESTABLISH. NO FURTHER INFORMATION IS AVAILABLE ON THE PRODUCT AT THIS TIME. THE DEVICE IN USE AND PHOTOGRAPHIC EVIDENCE WAS NOT AVAILABLE. HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED OR SAMPLE IS RETURNED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

Description of Event or Problem

ASPEN SURGICAL RECEIVED A REPORT FROM THE END USER INDICATING THAT DURING A PROCEDURE, THE SCALPEL CAME OFF OF THE SCALPEL HANDLE WHICH REQUIRED RETRIEVAL. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. THE DEVICE WAS IN USE DURING THE ALLEGED MALFUNCTION/EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS NUMBER C(B)(4).